Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05302856
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess whether the presence of Cytomegalovirus (CMV) Immunoglobulin G (IGG) antibodies in semen is a reliable predictor of male subfertility or infertility.
Detailed Description:
Prospective cohort study performed in the artificial reproductive technology (ART) unit.
The study will evaluate semen and serum samples from the following groups:
1. Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).
2. Subfertile/infertile male patients with abnormal semen analysis.
3. Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.
The study will evaluate semen and serum samples from the following groups:
1. Presumably fertile male patients going through ART treatment (for preimplantation genetic testing (PGT) or female indications).
2. Subfertile/infertile male patients with abnormal semen analysis.
3. Male patients suffering from unexplained infertility. All samples will be collected on the day of ovum retrieval procedure, and the semen samples will be evaluated only after completing the fertilization process. The samples will be tested for CMV IGG antibodies and testosterone levels in semen and serum. In addition, anti-sperm antibodies will be measured in the serum. The ratio between CMV IGG antibodies in semen and serum will be calculated, and will be compared with presence of hormone profile, semen analysis parameters and ART parameters.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: